COLGATE TOTAL® TOOTHPASTE WITH TRICLOSAN: THE TRUSTED CHOICE OF DENTISTS

Colgate Total® has been the trusted choice for healthy teeth and gums for more than 20 years. Worldwide, it’s the brand recommended most by dentists.

Colgate Total® toothpaste is uniquely formulated with 0.3% of the antibacterial ingredient triclosan to fight harmful plaque germs, which are the cause of most common oral health problems.

There are more published, peer-reviewed clinical studies of Colgate Total® than of any other toothpaste in the world. The efficacy and safety of Colgate Total® is supported by more than 90 clinical studies, involving over 20,000 people, and a broad set of safety evaluations. Our research has been shared with regulatory agencies around the world who have accepted triclosan’s safe and effective use in toothpaste.

Colgate Total® is clinically proven to work better than other toothpastes in reducing the germs that can cause gum disease. It is clinically proven to provide 12-hour protection against plaque germs that can lead to gingivitis, an early form of gum disease. Over 75% of American adults suffer from gingivitis. Plaque and gingivitis, if unchecked, can progress to periodontitis, a more serious and damaging stage of infection that can result in tooth and bone loss. According to the Centers for Disease Control and Prevention, almost half of American adults age 30 and over have serious periodontal disease.

Brushing with regular fluoride toothpaste does not provide the antibacterial protection of Colgate Total®toothpaste. On the US FDA’s website, updated as of September 2, 2016, the FDA states as follows regarding Colgate Total® toothpaste: "For some consumer products, there is evidence that triclosan provides a benefit." The FDA notes that it has “reviewed extensive effectiveness data on triclosan in Colgate Total toothpaste" and that the "evidence showed that triclosan in that product was effective in preventing gingivitis."

Additionally, only Colgate Total® toothpaste provides both antibacterial protection and direct anti-inflammatory action, which is notable given the importance of good oral health and the emerging scientific research associating oral health with overall health.

A thorough independent review was conducted and published by the Cochrane Oral Health Group on the oral health benefits of triclosan/copolymer, the active antibacterial system in Colgate Total® toothpaste. The Cochrane Review evaluated 30 studies dating from 1990 to 2012 and involving 14,835 participants (Riley & Lamont 2013). The resulting data highlighted the many clinical benefits of using a fluoride toothpaste containing triclosan/copolymer and concluded there was no evidence of any harmful effects associated with the use of triclosan/copolymer toothpastes in studies up to three years in duration. Among other things, the Cochrane Review found that after six or more months of use, fluoride toothpaste containing triclosan/copolymer provided:

22% reduction in plaque and gingivitis as compared with traditional fluoride toothpaste

How can triclosan be safe in toothpaste, but not in soap?

Colgate Total is the most extensively tested and reviewed toothpaste in the world, with more published, peer-reviewed clinical studies than any other toothpaste. Colgate Total users can be fully confident in the safety of our toothpaste and the important health benefit it provides fighting plaque and gingivitis.

So why are there press reports raising questions about the safety of Colgate Total? The issue has mostly been sparked by a new US Food and Drug Administration rule not on toothpaste, but on soap.

The US FDA on September 6, 2017 is implementing its final rule on consumer antibacterial hand wash products prohibiting the use of triclosan and 18 other antibacterial ingredients. The FDA did not conclude the ingredients were unsafe or ineffective. But it did find that soap manufacturers had not submitted requested safety evidence or enough proof that the products were more effective than washing with regular soap and water. In guidance accompanying the new rule, the FDA noted that manufacturers that want to continue to use the ingredients must submit the required evidence through its New Drug Application (NDA) approval process.

Colgate Total toothpaste has already been approved through the FDA’s NDA process, which is the same rigorous review the agency conducts for prescription medications. After an exhaustive review, the agency concluded that Colgate Total provides a meaningful therapeutic benefit and is safe for consumers. Colgate Total’s NDA approval has not changed in any way.

NDA safety testing for Colgate Total, like any new drug, requires a comprehensive evaluation covering a wide array of toxicological endpoints, such as carcinogenicity, reproductive and developmental toxicity, eye and skin irritation, and short term and long term toxicity. The original NDA submission for Colgate Total contained 98 volumes and included well over 100 toxicology studies.

And it doesn’t end there. The NDA approval also requires ongoing monitoring and safety updates that are provided by Colgate to the FDA annually.

The full weight of scientific evidence amassed over 25 years continues to support the safety and efficacy of Colgate Total. It is the only toothpaste that is both approved through the FDA’s NDA process and accepted by the American Dental Association as safe and effective in helping to prevent gingivitis. Consumers can be confident in their choice of Colgate Total.